Vaginal insert and method for treating urogenital disorders

ABSTRACT

A vaginal insert and method for delivering an agent to a urogenital tract in a patient, the patient having a vagina, the vagina having anterior and posterior walls. The vaginal insert comprises a main portion and first and second portions operably connected to the main portion. The first and second portions each have an end projecting outward from the main portion, at least one of the projecting ends has means for containing the agent. The projecting ends of the first and second portions are configured to engage the anterior vaginal wall while the main portion engages the posterior vaginal wall, thereby positioning the projecting end of the first portion proximal to one side of the urogenital tract and positioning the projecting end of the second portion proximal to an opposite side of the urogenital tract.

TECHNICAL FIELD

The present invention relates to the treatment of urogenital disordersand more particularly to a vaginal insert and method for delivering anagent to a urogenital tract.

BACKGROUND

Urinary incontinence is an involuntary discharge of urine from thebladder. Incontinence can be caused by a variety of factors includingpregnancy, estrogen deficiency, general weakening of the spectral pelvicfloor muscles, surgery along the urinary tract, infection, and othermaladies localized in the urinary tract. In addition to incontinence,women can experience chronic pain and infections along the urinarytract. These conditions are widespread and affect millions of people.

There are several types of incontinence, including stress incontinence,urge incontinence, and total incontinence. Stress incontinence occurswhen a person's body is under physical stress. People suffering fromthis type of incontinence might experience urine discharge duringphysically stressful events. Examples of stressful events includecoughing, laughing, and rigorous exercise.

Urge incontinence is characterized as an urgent desire to urinate andresults in total discharge of the bladder. During urge incontinence, thedetrusor muscle contracts or spasms inappropriately as the bladderfills. Such a contraction can occur suddenly, without warning, and isfrequently accompanied by a strong desire to void the bladder. Unstablebladder activity caused by urge incontinence is a common type ofincontinence in females. This type of incontinence can occur at anytime, but frequently occurs when a person has a sudden change in theirphysical position. Total incontinence is characterized by a total lackof control over urine discharge and is frequently caused by completefailure of the sphincter muscles.

For practical purposes, treatments for an unstable bladder are dividedinto simple and complex therapy. Simply therapy includes behavioralmodification and drug therapy, while complex therapy encompasseselectrical stimulation and radical surgery, which is performed either todenervate the bladder or to augment its capacity.

When treating detrusor instability, the use of therapeutic agents suchas drugs represents a pharmacologic attempt to interfere with bladdersmooth muscle contraction. Various agents may work at several differentpoints in the physiologic pathway leading to detrusor contraction.Possible sites of action include modulating control mechanisms in thecentral nervous system, blocking the activity of acetylcholine (which isthe major neurotransmitter in the bladder), directly relaxing bladdersmooth muscle, or regulating other substances believed to have amodulating effect on bladder contractile function. Agents that areuseful in treating detrusor instability may be broken down into at leastsix categories: anticholinergic drugs, antispasmodic or spasmolyticdrugs, tricyclic antidepressants, calcium channel blockers,prostaglandin synthetase inhibitors, and estrogens.

Because the main neuroreceptor involved in bladder contraction isacetylcholine, most agents used in treating detrusorinstability/hyperreflexia are drugs having significant anticholinergicproperties, even if these properties are not the main mechanism ofaction when the drugs are categorized pharmacologically. Theprototypical anticholinergic drug is atropine, a powerful belladonnaalkaloid that exerts its effects through competitive antimuscarinicactivity at parasympathetic neuroreceptor junctions. These effects arefelt in many organ systems, including the bladder.

Because these receptors are found in many parts of the body, the use ofany anticholinergic drug will produce effects on many physiologicparameters, not just those related to bladder function. Atropine is farmore potent than any of the drugs used in the treatment of detrusor overactivity. However, there has been little progress in developinganticholinergic drugs that act specifically on the bladder. As a result,the side effect patterns of these other drugs will follow roughly thesame dose-response pattern as atropine.

The most common side effects that may be experienced include a dry mouthdue to suppression of salivary and oropharyngeal secretions, occasionaldrowsiness, constipation due to decreased gastrointestinal motility,increased heart rate due to vagal blockade, and transient blurring ofvision due to blockade of the sphincter of the iris and the ciliarymuscle of the lens of the eye. Delivering agents to treat disordersother than detrusor instability can also cause serious side effects orharm to the patient.

Therefore, there is a need in the art for methods and apparatuses fortreating various maladies that effect the urinary tract. There is also aneed for methods and apparatuses for delivering an agent to tissueproximal to the urinary tract while minimizing exposure of the agent toother tissue.

SUMMARY

One embodiment of the present invention is directed to a vaginal insertfor delivering an agent to a urogenital tract in a patient, the patienthaving a vagina, the vagina having anterior and posterior walls. Thevaginal insert has a main portion and first and second portions operablyconnected to the main portion. The first and second portions each havean end projecting outward from the main portion, at least one of theprojecting ends is configured to contain the agent. The projecting endsof the first and second portions are configured to engage the anteriorvaginal wall while the main portion engages the posterior vaginal wall,thereby positioning the projecting end of the first portion proximal toone side of the urogenital tract and positioning the projecting end ofthe second portion proximal to an opposite side of the urogenital tract.

The present invention is also directed to a method of delivering anagent to a urogenital tract within a patient, the patient having avagina, the vagina having an anterior wall and a posterior wall. Themethod comprises the steps of inserting a vaginal insert into thevagina, the vaginal insert having a first and second projectingportions, the first projecting portions containing an agent; positioningthe first projecting portion on one side of the urogenital tract and thesecond portion on an opposite side of the urogenital tract; andtransporting the agent from the first projecting portion to theurogenital tract.

DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a vertical cross-section of the female genital and urinaryanatomy.

FIG. 2 shows a horizontal cross-section taken along line 2--2 of thefemale genital and urinary anatomy shown in FIG. 1.

FIG. 3 shows a perspective view of a vaginal insert used to deliver anagent to the urogenital tract.

FIG. 4 shows a partial cross-section of the device shown in FIG. 3, thepartial cross-section taken along line 4--4.

FIG. 5 shows an alternative embodiment of the vaginal insert used todeliver an agent to the urogenital tract.

FIG. 6 shows a partial cross-section of the device shown in FIG. 5, thepartial cross-section taken along line 6--6.

FIG. 7 shows a cross-section of an alternative embodiment of the vaginalinsert used to deliver an agent to the urogenital tract.

FIG. 8 shows a cross-section of another alternative embodiment of thedevice used to deliver an agent to the urogenital tract.

FIG. 9 shows a cross-section of an alternative embodiment of a vaginalinsert useful for delivering an agent to the urogenital tract.

FIG. 10 shows an alternative embodiment of a vaginal insert useful fordelivering an agent to the urogenital tract.

FIG. 11A shows a cross-section of the device shown in FIG. 10, thecross-section taken along line 11--11.

FIG. 11B shows a cross-section of an alternative embodiment of thedevice shown in FIG. 10, the cross-section taken along line 11--11.

FIG. 12 shows an exploded view of an alternative embodiment of thevaginal insert useful for delivering an agent to the urogenital tract.

FIG. 13 shows a cross-section of the vaginal insert shown in FIG. 12,the cross-section taken along line 13--13.

DETAILED DESCRIPTION

The invention initially will be described in general terms inconjunction with a brief description of the female anatomy. The variousvaginal inserts and methods then will be described in detail withreference to the drawings, wherein like reference numbers represent likeparts and assemblies throughout the several views. Reference to thepreferred embodiment does not limit the scope of the invention, which islimited only by the scope of the claims attached hereto.

Referring to FIG. 1, the female body defines a urethra 20, whichprovides a discharge lumen that is in fluid communication with a bladder22. The urethra 20 meets the bladder 22 at the bladder neck 24. Theurethra 20, bladder 22, and bladder neck 24 are individual parts of theurinary tract. Additionally, a vagina 26 is located directly behind theurethra 20 and leads to the cervix 28 and the uterus 30. The vagina hasanterior and posterior walls 32 and 34 respectively. Only a thin layerof tissue is located between the urethra 20 and the anterior vaginalwall 32.

The present invention generally relates to an apparatus and method ofinserting an agent into the vagina 26 and transporting that agent fromthe vagina 26, through the anterior vaginal wall 32, and to the tissuesurrounding the urinary tract. The target tissue surrounding the urinarytract can be the bladder 22, the neck 24 of the bladder 22, or theurethra 20. The techniques for transporting the agent from the vagina 26to the tissue surrounding the urinary tract can involve passive oractive delivery. Although the following description discusses deliveringthe agent to the urinary tract, the present invention can be used todeliver the agent to any tissue within the urogenital tract.

Examples of passive delivery include natural absorption. Examples ofactive delivery include iontophoresis; phonophoresis; andmagnetophoresis, which involves magnetic activation of the agent.

Additionally, the invention can be used to deliver agents for treating avariety of maladies such as incontinence; muscle spasms that haveundesirable results such as involuntary bladder contractions; urethralsyndrome; interstitial cystitis; and general maladies such as pain,infections, and diseased tissue. Various agents can be used to treatthese maladies including, but not limited to, anticholinergic drugs suchas atropine and ditropan, α-adrenergic agents, antispasmodic orspasmolytic drugs, tricyclic antidepressants, calcium channel blockers,prostaglandin synthetase inhibitors, estrogens, and other agents thatact on skeletomuscles.

The present invention has many advantages. One advantage is that theagent is delivered directly to the tissue surrounding the urinary tract.Exposure of the agent to other parts of the body, including thereproductive organs, is diminished. As a result, the risk of sideeffects is minimized. This advantage is very important when deliveringtoxic drugs or hormones that can cause cancer, especially when deliveryoccurs on a periodic or frequent basis.

Minimizing the amount of agent that is delivered outside of the urinarytract also reduces waste. Thus, a smaller dose of the agent can be usedwith the present invention while increasing its effectiveness. In otherwords, the agent that is delivered into the patient will be used muchmore efficiently.

FIGS. 3 and 4 illustrate a vaginal insert, generally shown as 36, thathas a main body or portion 38. The main body 38 is elongated and definesa main lumen 40. Additionally, the main body 38 is bent at anintermediate section 46.

A first member or portion 48 is operably connected to and projectsoutward from the main body 38. The first projecting member 48 has aprojecting end 50 and defines a first branch lumen 52 that is in fluidcommunication with a first balloon 54. The first balloon 54 is operablyconnected to the projecting end 50 and is formed from a porous membrane56.

A second projecting member or portion 58 is substantially similar to thefirst member 48. Specifically, the second member 58 is operablyconnected to the main body 38, has a projecting end 60, and defines asecond branch lumen (not shown). Additionally, a second balloon 62 isformed from a porous membrane 64 and is operably connected to theprojecting end 60. The second balloon 62 is in fluid communication withthe second branch lumen.

First and second projecting members 48 and 58 are positioned so thatthey form a gap or opening 65 therebetween. The gap 65 is sized toreceive the bladder neck 24 when the first and second projecting members48 and 58 engage the anterior vaginal wall 32. Additionally, the firstand second projecting members 48 and 58 are positioned so that when theyengage the anterior vaginal wall 32, the intermediate section 46 of themain body 38 engages the posterior vaginal wall 34.

A first electrode 66 is positioned within the first balloon 54. Thefirst electrode 66 is connected to a first lead 68 that extends throughthe first branch lumen 52 and the main lumen 40. The first lead 68 isthen connected to a power source 70. In one embodiment, a secondelectrode 72 is remotely located and is connected to the power supply 70by a second lead 74. In this configuration, the second electrode 72 is apatch-type electrode that can be placed against the patient's skin. Athird electrode (not shown) is substantially similar to the firstelectrode 66 and is located within the second balloon 62. A third lead(not shown) connects the third electrode to the first lead 68 so thatthe first 66 and third electrodes have the same polarity.

The power supply 70 can be a simple DC power source that provides adirect current between the first and third electrodes and the secondelectrode. Alternatively, the power supply 70 can provide a currenthaving a predetermined type of waveform. Additionally, the power supplycan provide an electric current at intermittent intervals.

In use, the vaginal insert 36 is placed within the vagina 26 andoriented so that the first and second balloons 54 and 62 engage andpress into the anterior vaginal wall 20 so that the bladder neck 24 ispositioned within the gap 65. In this position, the intermediate sectionengages the posterior vaginal wall 34 providing frictional engagement tosecure the vaginal insert 36 in a stationary position. One skilled inthe art will realize that the first and second balloons 54 and 62 can bepositioned along other portions of the urinary tract such as the urethra20.

After the vaginal insert 36 is secured in position, a fluid containingan agent is injected into the main lumen 40 so that the fluid flowsthrough the first 52 and second branch lumens and inflates the first andsecond balloons 54 and 62. The second electrode 72 is placed against thepatient's body at a position such as the patient's abdomen or thigh. Thepower supply 70 is then activated, which causes a current to flowbetween the first 66 and third electrodes and the second electrode 72.Electrons that form the current will flow from the first 66 and thirdelectrodes, through the anterior vaginal wall 32, through the tissueproximate to the bladder neck 24, and to the second electrode 72. Theelectrons carry the agent from the first and second balloons 54 and 62to the tissue proximate to the bladder neck 24.

One skilled in the art will realize that the vaginal insert 36 shown inFIG. 3 can have many alternative embodiments. For example, the first andsecond balloons 54 and 62 can be replaced with hollow spheres (notshown) that define a plurality of delivery ports. In this embodiment,the spheres may be covered with a porous membrane (not shown) to diffusethe current and prevent a hot spot at tissue that is adjacent to thedelivery ports.

In another alternative embodiment, the first and second balloons 54 and62 can be replaced with solid spheres (not shown) that have surfacemounted electrodes (not shown) and are covered with a material (notshown) that can be impregnated with and release the agent. The materialmight be configured to naturally release the agent or to release theagent only if subjected to some type of active delivery mechanism suchas iontophoresis or phonophoresis. Examples of suitable materialsinclude a polymer matrix such as a hydrogel, a foam such as an open cellfoam or a hydrophilic foam, and or any other material that can containand release the agent.

In yet another alternative embodiment, the main body 38 defines firstand second main lumens (not shown). The first main lumen is in fluidcommunication with the first balloon 54 via the first branch lumen 52.The second main lumen is in fluid communication with the second balloon62 via the second branch lumen (not shown). In this embodiment, thefirst electrode 66 is positioned in the first balloon 54 and the secondelectrode 70 positioned in the second balloon 62. The first lead 68extends through the first branch lumen 52 and the first main lumen. Thesecond lead 74 extends through the second branch lumen and the secondmain lumen. Finally, the first and second leads 68 and 74 are connectedto the power supply 70 in a manner that creates a bipolar electrodeconfiguration.

An advantage of this design is that two agents can be simultaneouslydelivered. The first fluid having an agent and charged ions of onepolarity are injected into the first balloon 54 and a second fluidcontaining an agent and ions of an opposite polarity are injected intothe second balloon 62. As a result, two different agents can besimultaneously delivered, which can minimize the overall length of timerequired to deliver the prescribed dose of agents.

Additionally, the same agent can be delivered from both the first andsecond balloons 54 and 62 using a bipolar configuration. Delivery inthis manner is accomplished by linking the agent that is injected intothe first balloon 54 to ions having one polarity and the agent that isinjected into the second balloon 62 to ions having an opposite polarity.An advantage of this type of delivery is that the current density can bedecreased, while still delivering the agent in an acceptable amount oftime. Reducing the current density will help to alleviate the discomfortexperienced by the patient. An alternative advantage is that deliverycan be performed twice as fast, thereby minimizing the length of timethe patient is in discomfort.

FIG. 5 illustrates an alternative vaginal insert, generally shown as 76,in which a first member or portion 78 is operably connected to the mainportion 38, has a projecting end 80, and has a curved segment 82 that isshaped to conform to the bladder neck 24. The curved segment 82 can havea C-shaped configuration. Additionally, the first projecting member 78defines a first branch lumen 84 that is in fluid communication with themain lumen 40. Delivery ports 86 are defined in the curved segment 82and are in fluid communication with the first branch lumen 84.

The second projecting member 88 is substantially similar to the firstprojecting member 78 and has a projecting end 90, a curved segment 92, asecond branch lumen (not shown) that is in fluid communication with themain lumen 40, and delivery ports 94 that are in fluid communicationwith the second branch lumen. Additionally, the second projecting member88 has a flexible segment 97 that allows the first and second projectingmembers 78 and 88 to move between an open state and a closed state.

When in a closed state, the projecting ends 80 and 90 of the first andsecond projecting members 78 and 88 are adjacent to one another. In theclosed state, the curved segments 82 and 92 form a gap or opening 96that is sized to allow the bladder neck and proximal tissue to passtherethrough. When in the open state, the opening 96 is configured toreceive the bladder neck 24 and proximal tissue.

Referring to FIG. 6, a first electrode 98 is positioned in the firstbranch lumen 84 and is connected to the first lead 68 that extendsthrough the main lumen 40. The second electrode 72 is remotely locatedand connected to the second lead 74. A third electrode (not shown) ispositioned in the second branch lumen and is also connected to the firstlead 68. The power supply 70 is connected to the first and second leads68 and 74 so that the polarity of the first 98 and third electrodes isopposite to the polarity of the second electrode 72.

In use, the vaginal insert 76 is inserted into the vagina 26 so that thefirst and second projecting members 78 and 88 are in the open state andengage the anterior vaginal wall 32, thereby projecting along oppositesides of the bladder neck 24. The first and second projecting members 78and 88 are then shifted to the closed state so that the delivery ports86 and 94 substantially circumscribe the bladder neck 24. Fluid is theninjected through the main lumen 40 so that it seeps through the deliveryports 86 and 94. Simultaneously, current is passed between the first 98and third electrodes and the second electrode 72. The iontophoreticcurrent helps to transport the fluid through the tissue of the anteriorvaginal wall 32 and to the tissue proximal to the bladder neck 24. Ifthe vaginal insert 76 has a bipolar configuration, fluids containingagents with oppositely charged ions can be injected into the first 84and second branch lumens, respectively.

Similar to the embodiment shown in FIG. 3, one skilled in the art willrealize that the vaginal insert 76 also can be configured to have abipolar configuration in which the first electrode 98 having onepolarity is positioned in the first branch lumen and the secondelectrode 72 having an opposite polarity is positioned in the secondbranch lumen. The main body 38 has first and second main lumens (notshown). The first lead 68 extends through the first main lumen and thesecond lead 74 extends through the second main lumen.

Additionally, the first and second projecting members 78 and 88 can becovered with a polymer matrix to help diffuse the current density andprevent hot spots at tissue adjacent to the delivery ports 86 and 94.One skilled in the art will also realize that the first and secondprojecting members 78 and 88 can be formed from a solid material; canhave surface mounted electrodes; and can be coated with a material suchas polymer matrix, hydrogel, or foam that is impregnated with an agent.Alternatively, the first and second projecting members 78 and 88 can beformed from the agent-retaining material itself.

FIG. 7 illustrates yet another alternative embodiment. In thisembodiment, a vaginal insert, generally shown as 100, has a U-shape anddefines a main portion 102 that is central between first and secondportions 104 and 106. First and second portions 104 and 106 have acircumference that is smaller than the circumference of the main portion102. Additionally, a first electrode 108 is wound around the firstportion 104 and a second electrode 110 is wound around the secondportion 106. The first and second electrodes 108 and 110 are connectedto a power supply 112 via first and second leads 114 and 116.

The first portion 104 and first electrode 108 are covered by a first cap118 formed from an absorbent material such as a polymer matrix, ahydrogel, or a foam. Any of these substances can be impregnated with anagent. The second portion 106 and second electrode 110 are similarlycovered with an absorbent material that can be impregnated with anagent.

One skilled in the art will realize that the power supply 112 can haveseveral possible configurations. In one configuration, the power supply112 can be a battery that provides a simple direct current. In thissituation, the patient would activate the power supply 112 before thevaginal insert 100 is placed in the vagina 26. In an alternativeembodiment, the power supply 70 contains an inductive coil, similar tothat of a transformer. In this embodiment, the vaginal insert 100 ispositioned within the vagina 26 and the patient or caregiver can place amagnetic source against the body and proximal to the power supply 70.The magnetic source will generate a field that induces an electricalcurrent in the magnetic coil.

In yet another embodiment, the inductive circuit is a resonant circuitthat is tuned to a frequency in the radio frequency (RF) range (i.e.,greater than about 9 KHz). In this embodiment, the resident circuitinduces an electrical current when subject to a magnetic field that isoscillating at the resident frequency. One skilled in the art willrealize that the power supply 112 can include an AC/DC converter so thata direct current is passed between the first and second electrodes 108and 110. Alternatively, the power supply 112 can include additionalcircuitry to generate a current having a particular waveform. Anadvantage of using a resonant circuit is that interference from straymagnetic fields is minimized.

In use, the first cap 118 is impregnated with an agent having apre-determined polarity. Additionally, the second cap 120 can beimpregnated with an agent having an opposite polarity. The vaginalinsert 100 is positioned within the vagina 26 so that the first andsecond portions 104 and 106 engage the anterior vaginal wall 32 and arepositioned along opposite sides of the urinary tract. The main portionthen engages the posterior vaginal wall 34, thereby securing the vaginalinsert 100 in a stationary position. One skilled in the art will realizethat the vaginal insert 100 can be positioned proximal to any portion ofthe urinary tract such as the bladder neck 24 or the urethra 20. Theelectric current then passes between the first and second electrodes 108and 110 and transports the agent from the first and second caps 118 and120 to tissue proximal to the urinary tract that is located and betweenthe first and second portion 104 and 106.

FIG. 8 illustrates another alternative embodiment that has aconfiguration substantially similar to the vaginal insert 100 and usesmagnetophoresis to transport the agent. In particular, the vaginalinsert, generally shown as 122, has a main portion 124, a first portion126, and a second portion 128. First and second caps 130 and 132 formedof an agent-retaining material such as a polymer matrix cover the firstand second portions 126 and 128, respectively. The first and second caps130 and 132 are impregnated with magnetic particles in addition to anagent. In use, the vaginal insert 122 is positioned in the vagina 26 sothat a portion of the urinary tract is positioned between the first andsecond portion 126 and 128. A user can then place a magnetic sourceagainst their body. The magnetic source generates a field that causesthe magnetic particles to vibrate. This vibrating action drives theagent from the caps 130 and 132, through the anterior vaginal wall 32,and into tissue proximal to the patient's urinary tract.

Referring to FIG. 9, another vaginal insert, generally shown as 134, hasa base member 136 having a delivery portion 138 and a handle portion140. The delivery portion 138 defines a chamber 142 and plurality ofports 144. A first electrode 146 is wound around the delivery portion138. A first lead 149 extends from the first electrode 146 and throughthe handle portion 140 so that it may be connected to the power source70.

A membrane 148 is operably connected to the base member 136 and definesa reservoir 150. The membrane 148 has a porous section for engaging theanterior vaginal wall 32. The ports 144 provide fluid communicationbetween the chamber 142 and the reservoir 150. Additionally, the poroussection of the membrane 148 can be located in only that portion of themembrane 148 that is placed against the anterior vaginal wall 32,thereby minimizing the amount of tissue outside of the urinary tractthat is exposed to the agent. However, one skilled in this art willrealize that the entire membrane 148 could be porous.

The handle portion 140 defines a supply port 152 that is covered by aseptum 154, which seals if punctured by a needle. The supply port 152provides a passage for supplying fluid into the chamber 142 and thereservoir 150. A second electrode 156 is a patch-type electrode andconfigured to be placed against the patient's body. The second electrode156 has a second lead 158 for connecting to the power source 70.

In use, a patient or caregiver will inject a fluid containing an agentthrough the supply port 152 and fill the reservoir 150 and chamber 142.The fluid is supplied in an amount that fills the reservoir 150 with apressure that permits the membrane 148 to remain pliable. The vaginalinsert 134 is then placed in the vagina 26 so that the pores in themembrane 148 engage the anterior vaginal wall 32. The second electrode156 is then placed against the patient's body at a position such as thepatient's abdomen or thigh. The power supply 70 is activated so that aniontophoretic current passes between the first and second electrodes 146and 156 and transports the agent from the reservoir 150 to tissuessurrounding the urinary tract.

An advantage of vaginal insert 134 is that upon insertion, the vaginalwalls will exert pressure against the membrane 148 and cause the fluidand agent to pass through the pores and through the anterior vaginalwall 32 where the agent can be absorbed by tissue surrounding theurinary tract.

FIGS. 10 and 11A illustrate another vaginal insert, generally shown as160, having a base member 162 and a first electrode 164 mounted on asurface 166 of the base member 162. The first electrode 164 is connectedto the power source 70 via a first lead 167. A second, patch-typeelectrode 168 is configured to be placed against the skin and isattached to the power source 70 via a lead 170. An agent-retainingmember 172 is operably connected to the base member 162 and has an outersurface 174. The base member 162 and agent-retaining member 172 arecurved, thereby defining a channel 176 that is sized to engage theanterior vaginal wall 32 and receive tissue proximal the urethra 20. Inthis configuration, the agent-retaining member 172 can be formed from amaterial such as polymer matrix, hydrogel, or hydrophilic foam that canbe impregnated with the agent. The agent-retaining member 172 isimpregnated with an agent.

In use, the vaginal insert 160 is placed in the vagina 26 so that thecurved outer surface 174 engages the anterior vaginal wall 32 and thechannel 176 receives the tissue surrounding the urethra 20. The secondelectrode 168 is then placed against the patient's abdomen or thigh andthe power source 70 is activated. The iontophoretic current passesbetween the first and second electrodes 164 and 168 and transports theagent from the agent-retaining member 172 to the tissue proximal to theurethra 20.

In an alternative embodiment illustrated in FIG. 11B, the base member162 can define a chamber 163 and a plurality of delivery ports 165. Thedelivery ports provide fluid communication between the chamber 163 andthe surface of base member 162. An electrode 169 is positioned withinthe chamber 163. The electrode is operably connected to the first lead167. The base member 162 also defines a hole (not shown) that is coveredby a septum (not shown). In order to fill the chamber, the user cansimply inject the agent or a solution containing the agent through theseptum.

This alternative embodiment may contain the agent-retaining member 172.If the agent-retaining member 172 is used, it may contain a secondtherapeutic agent or a penetration enhancer. Alternatively, theagent-retaining member could be loaded only with water in order toprovide a path for the iontophoretic current that passes between theelectrodes 169 and 168. One skilled in the art will realize that thealternative embodiment shown in FIG. 11B is used in a substantiallysimilar manner to the embodiment shown in FIG. 11A.

Referring to FIGS. 12 and 13, another vaginal insert, generally shown as178, has a base member 180 on which a first electrode 182 is mounted.The first electrode 182 is connected to a power source 70 via a firstlead 184. A second, patch-type electrode 186 is configured to be placedagainst the patient's body at a point such as the abdomen or thigh. Thesecond electrode 186 is then is connected to the power source 70 via asecond lead 188. A cotton-fiber matrix 190 is mounted on the basemember. The cotton-fiber matrix is absorbent and swells when it becomeswetted. One skilled in the art will realize that other materials thatcan be impregnated with an agent and that swells when wetted can besubstituted for the cotton-fiber matrix 190.

The base member 180 and cotton-fiber matrix 190 are sized to fit withina tubular tampon-like applicator 192 when the cotton-fiber matrix 190 isnot wetted. The tampon-like applicator 192 has a leading end 194 that isopen and a trailing end 196 that is open.

In use, a user will position the base unit 180 and unwetted cotton-fibermatrix 190 in the tampon-like applicator 192 so that the first lead 184extends through the trailing end 196. The cotton-fiber matrix 190 isthen wetted with a fluid that contains an agent. The user uses thetampon-like applicator 192 to insert the base member 180 andcotton-fiber matrix 190 combination into the vagina 26 much like atampon. During this process, the cotton-fiber matrix 190 expands as itis pushed out of the leading end 194 of the tampon-like applicator 192.After the tampon-like applicator 192 is removed from the vagina 26, theswelled cotton-fiber matrix 190 will conform to the contours of theinterior vaginal wall. The second electrode 186 is placed against thepatient's body at a point such as the abdomen or thigh. When an electriccurrent passes between the first and second electrodes 182 and 186, theagent will be transported from the cotton-fiber matrix 190 to tissuesurrounding the urinary tract, including the urethra 20.

One skilled in the art will realize that any of the embodimentsdescribed above can use alternative methods to transport the agent. Forexample, the active transport mechanism can be phonophoresis in whichthe electrodes are be replaced with an ultrasonic transducers.Phonophoresis uses ultrasonic waves to transport the agent from thevaginal insert to the target tissue that is proximal to the urinarytract. Another alternative transport mechanism is magnetophoresis. amagnetophoresis transport mechanism has both an agent and magneticparticles impregnated in an agent-retaining material that forms part ofthe vaginal insert. The magnetic particles will vibrate when subjectedto an oscillating magnetic field, thereby driving the agent toward thetarget tissue. Additionally, all of the embodiments described above canbe used with passive delivery, in which case electrodes, ultrasonictransducers, and magnetic particles are not necessary. One skilled inthe art will also realize that any agent-retaining material may besubstituted for a polymer matrix, hydrogel, or foam.

Although the description of vaginal inserts and methods has been quitespecific, it is contemplated that various modifications could be made.Accordingly, it is intended that the scope and spirit of the presentinvention can be dictated by the appended claims, rather than by theforegoing description.

The claimed invention is:
 1. A vaginal insert for delivering an agent toa urogenital tract in a patient, the patient having a vagina and aurethra, the vagina having anterior and posterior walls, the vaginalinsert comprising:a main portion; first and second portions operablyconnected to the main portion, the first and second portions each havingan end projecting outward from the main portion, at least one of theprojecting ends being configured to contain the agent; a first electrodeproximate the projecting end of the first portion and a second electroderemote from the first electrode, the first and second electrodesconfigured to be placed in electrical communication with a power sourceso that the first and second electrodes have opposite polarity; andwherein the projecting ends of the first and second portions beingconfigured to engage the anterior vaginal wall, thereby positioning theprojecting end of the first portion proximal to one side of the urethraand positioning the projecting end of the second portion proximal to anopposite side of the urethra and the first portion defines a chamber anda port that is in fluid communication with the chamber.
 2. The vaginalinsert of claim 1 wherein the main portion defines a lumen, the lumenbeing in fluid communication with the chamber, further wherein theapparatus comprises a balloon formed from a porous membrane and in fluidcommunication with the port.
 3. The vaginal insert of claim 1 whereinthe second portion defines a chamber and a port that is in fluidcommunication with the chamber, the vaginal insert further comprising:afirst balloon formed from a porous membrane, the first balloon beingoperably connected to the first portion and in fluid communication withthe port of the first portion; and a second balloon formed from a porousmembrane, the second balloon being operably connected to the secondportion and in fluid communication with the port of the second portion.4. A vaginal insert for delivering an agent to a urogenital tract in apatient, the patient having a vagina and a urethra, the vagina havinganterior and posterior walls, the vaginal insert comprising:a mainportion; first and second portions operably connected to the mainportion, the first and second portions each having an end projectingoutward from the main portion; foam covering a portion of the projectingend of the first portion, the foam configured to be impregnated with theagent; and wherein the projecting ends of the first and second portionsbeing configured to engage the anterior vaginal wall, therebypositioning the projecting end of the first portion proximal to one sideof the urethra and positioning the projecting end of the second portionproximal to an opposite side of the urethra.
 5. The vaginal insert ofclaim 4 wherein the means for containing an agent includes foam coveringa portion of the projecting end of the first portion and the secondportion, the foam configured to be impregnated with the agent.
 6. Thevaginal insert of claim 3 wherein the foam is configured to release theagent when placed in contact with the vaginal wall.
 7. A vaginal insertfor delivering an agent to a urogenital tract in a patient, the patienthaving a vagina and a urethra, the vagina having anterior and posteriorwalls, the vaginal insert comprising:a main portion; first and secondportions operably connected to the main portion, the first and secondportions each having an end projecting outward from the main portion; apolymer matrix covering a portion of the projecting end of the firstportion and the second portion, the polymer matrix configured to beimpregnated with the agent; and wherein the projecting ends of the firstand second portions being configured to engage the anterior vaginalwall, thereby positioning the projecting end of the first portionproximal to one side of the urethra and positioning the projecting endof the second portion proximal to an opposite side of the urethra. 8.The vaginal insert of claim 7 wherein the means for containing an agentincludes a first polymer matrix covering a portion of the projecting endof the first portion and a second polymer matrix covering a portion ofthe projecting end of the second portion, the first and second polymermatrixes configured to be impregnated with the agent.
 9. The vaginalinsert of claim 8 wherein the polymer matrix is configured to releasethe agent when place in contact with the vaginal wall.
 10. The vaginalinsert of claim 8 wherein the polymer matrix is configured to dissolvewhen place in the vagina, thereby releasing the agent.
 11. The vaginalinsert of claim 8 wherein the polymer matrix contains magneticparticles, wherein the magnetic particles vibrate when subjected to anoscillating magnetic field.
 12. The vaginal insert of claim 11 furthercomprising an internal circuit, the internal circuit being configured togenerate an oscillating magnetic field thereby causing the magneticparticles to vibrate.
 13. The vaginal insert of claim 12 wherein theinternal circuit is a resonant circuit.
 14. A vaginal insert fordelivering an agent to a urogenital tract in a patient, the patienthaving a vagina and a urethra, the vagina having anterior and posteriorwalls, the vaginal insert comprising:a main portion; first and secondportions operably connected to the main portion, the first and secondportions each having an end projecting outward from the main portion, atleast one of the projecting ends being configured to contain the agent;an ultrasonic transducer operably connected to the first portion, theultrasonic transducer being configured to be placed in electricalcommunication with a power source, thereby causing the ultrasonictransducer to emit ultrasonic waves and drive the agent toward theurogenital tract; and wherein the projecting ends of the first andsecond portions being configured to engage the anterior vaginal wall,thereby positioning the projecting end of the first portion proximal toone side of the urethra and positioning the projecting end of the secondportion proximal to an opposite side of the urethra.
 15. The vaginalinsert of claim 14 further comprising an internal power source beingoperably connected to the ultrasonic transducer.
 16. The vaginal insertof claim 15 wherein the internal power source is an inductive circuitthat generates a current when subjected to a magnetic field.
 17. Avaginal insert for delivering an agent to a urogenital tract in apatient, the patient having a vagina and a urethra, the vagina havinganterior and posterior walls, the vaginal insert comprising:a mainportion, the main portion being an elongated member configured to extendlengthwise in the vagina; first and second portions operably connectedto the main portion, the first and second portions each having an endprojecting outward from the main portion, at least one of the projectingends being configured to contain the agent, the first and secondportions extending outward from the elongated member thereby forming agap for receiving tissue surrounding a portion of the urogenital tract;and wherein the projecting ends of the first and second portions beingconfigured to engage the anterior vaginal wall, thereby positioning theprojecting end of the first portion proximal to one side of the urethraand positioning the projecting end of the second portion proximal to anopposite side of the urethra.
 18. A vaginal insert for delivering anagent to a urogenital tract in a patient, the patient having a vaginaand a urethra, the vagina having anterior and posterior walls, thevaginal insert comprising:a main portion; first and second portionsoperably connected to the main portion, the first and second portionseach having an end projecting outward from the main portion, at leastone of the projecting ends being configured to contain the agent;wherein the projecting ends of the first and second portions beingconfigured to engage the anterior vaginal wall, thereby positioning theprojecting end of the first portion proximal to one side of the urethraand positioning the projecting end of the second portion proximal to anopposite side of the urethra; and wherein the first and second portionsdefine an opening, have an open state, and have a closed state, theopening being configured to receive the bladder neck when the first andsecond portions are in the open state, and the first and second openingsare configured to substantially circumscribe the bladder neck when inthe closed state.
 19. The vaginal insert of claim 18 wherein the firstand second portions each have a C-shaped segment.
 20. A method ofdelivering an agent to a urogenital tract within a patient, the patienthaving a vagina and a urethra, the vagina having an anterior wall and aposterior wall, the method comprising the steps of:inserting a vaginalinsert into the vagina, the vaginal insert having first and secondprojecting portions, the first projecting portion containing an agent;positioning the first projecting portion against the anterior vaginalwall and proximal one side of the urethra and the second projectingportion against the anterior vaginal wall and proximal an opposite sideof the urethra; and transporting the agent from the first projectingportion to the urogenital tract.
 21. The method of claim 20 wherein thevaginal insert includes a first electrode operably connected to thefirst projecting portion, the step of transporting the agent includingthe steps of:placing a second electrode in contact with the patient'sbody; and conducting a current between the first and second electrode sothat the current flows proximate the urogenital tract.
 22. The method ofclaim 20 wherein the vaginal insert contains a first electrode operablyconnected to the first projecting portion and a second electrodeoperably connected to the second projecting portion, the step oftransporting the agent including the step of conducting a currentbetween the first and second electrode so that the current flowsproximate the urogenital tract.
 23. The method of claim 21 wherein thevaginal insert includes an inductive circuit that generates a currentwhen subjected to a magnetic field, the step of transporting the agentfurther includes the step of subjecting the inductive circuit to amagnetic field.
 24. The method of claim 21 wherein the agent containedby the first projecting portion has one polarity and the secondprojecting portion contains an agent having an opposite polarity and asecond electrode, the step of transporting the agent including the stepsof:transporting the agent having one polarity from the first projectingportion to tissue proximate the urogenital tract; and transporting theagent having an opposite polarity from the second projecting portion totissue proximate the urogenital tract.
 25. The method of claim 20wherein the first projecting portion includes a polymer matrix forcontain the agent and magnetic particles, the step of transporting theagent includes the step of subjecting the magnetic particles to anoscillating magnetic field.
 26. The method of claim 20 wherein the firstand second projecting portions define a gap, have an open state, andhave a closed state, the gap being configured to receive the bladderneck when in the open state and configured to substantially surround thebladder neck when in the closed state, the method comprising theadditional steps of:placing the bladder neck in the gap while the firstand second projecting portions are in the open state; and shifting thefirst and second projecting portions from the open state to the closedstate so that the first and second projecting portions substantiallycircumscribe the bladder neck.
 27. A vaginal insert for delivering anagent to a urogenital tract in a patient, the patient having a vaginaand a urethra, the vagina having anterior and posterior walls, thevaginal insert comprising:a main portion; first and second portionsoperably connected to the main portion, the first and second portionseach having an end projecting outward from the main portion, at leastone of the projecting ends being configured to contain the agent; afirst electrode proximate the projecting end of the first portion and asecond electrode remote from the first electrode, the first and secondelectrodes configured to be placed in electrical communication with aresonant circuit having a resonant frequency so that the first andsecond electrodes have opposite polarity; and wherein the projectingends of the first and second portions being configured to engage theanterior vaginal wall, thereby positioning the projecting end of thefirst portion proximal to one side of the urethra and positioning theprojecting end of the second portion proximal to an opposite side of theurethra.